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510(k) Data Aggregation

    K Number
    K213660
    Device Name
    RadAlly
    Manufacturer
    Date Cleared
    2023-03-31

    (494 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Imaging Wave, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RadAlly™ is a software Medical Image Management and Processing System (MIMPS) intended to transfer, display, archive, and review medical images in DICOM format for diagnostic use by a licensed practitioner, such as a radiologist or any physician maintaining the correct licensing criteria to read and interpret medical images. RadAlly™ supports multimodality imaging such as Ultrasound (US), Digitized X-Ray Film (SC), Digital Radiography (DR), Computed Radiography (CR), Computed Tomography (CT), Magnetic Resonance (MR) Imaging. RadAlly™ is not intended for use with mammography - either film or full field digital mammography (FFDM) or tomosynthesis (Tomo or 3D Mammo). It is also not intended for use with nuclear medicine, PET, SPECT or CT fusion imaging. RadAlly™ is not indicated for use on mobile displays. RadAlly™ may be interfaced with other DICOM modalities or MIMPS systems. All pertinent patient information may be displayed simultaneously. The viewer includes standard image measurement tools such as distance. RadAlly™ also includes manual measurement tools for use with ultrasound cardiac imaging, including Pressure-Half Time (PHT), Velocity-Time Integral (VTI), Aortic Valve Area (MVA).
    Device Description
    RadAlly™ is a software MIMPS designed to receive, archive, and display medical images. RadAlly™ offers viewing tools such as zoom, pan, magnification, and window/level. It also offers manual measurement tools including distance measure, angle, and ultrasound cardiology measurements including PHT, VTI, AVA, and MVA. The user is intended to be a licensed practitioner, who uses the software to receive and view medical images as well as patient data. The software is designed for use on the following operating systems: Windows 10 and higher, MAC 10.10 and higher. RadAlly is compliant with ACR/NEMA DICOM 3.1-3.20. The software product may be installed on any PC or Mac hardware which is capable of running the stated operating systems. The hardware should include monitor, keyboard, mouse suitable for performing medical interpretation as stated for each modality by the ACR. The hardware must be web-enabled. The device s self-contained software and is not bundled with any other device. It does not have any separable modules or additional options. RadAlly™ is the only model number. RadAlly™ is software used to review medical images and patient information. It does not come into contact with patients, nor does it contain biologics or drugs. It is intended to be used to review multiple images sets. There are no coatings or additives. It does not require sterilization.
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